Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intracorporeal Anastomosis in Laparoscopic Left Colectomy. Cohort Comparative Study (RIAL-COLECTOMY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456933
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 17, 2020
Sponsor:
Collaborators:
Irene Gómez Torres
Laura Mora López
Anna Pallisera-Lloveras
Sheila Serra-Pla
Albert García Nalda
Anna Serracant-Barrera
Mercedes Muñoz
Oriol Pino-Pérez
Information provided by (Responsible Party):
Xavier Serra-Aracil, Corporacion Parc Tauli

Brief Summary:

OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage.

BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our surgical procedures in order to minimize exposure to the virus as much as possible.

Based on the recommendations in case of surgery in patients with highly contagious viral diseases, the latest studies suggest minimally invasive accesses to minimize the risk of contagion. One of the proposed measures is the performance of intracorporeal anastomoses. Therefore, given the extensive experience of our center in minimally invasive surgery and studies on the validation of intracorporeal anastomosis techniques in both laparoscopic surgery of the right colon and rectum (TaTME), and the study of advantages that they can provide to the patient, our intention is to apply it to surgery on the left colon, sigma and upper rectum. Our hypothesis is that exteriorization of the colon through an accessory incision increases the risk of tension at the mesocolon level, thus increasing the risk of vascular deficit at the level of the staple area and it may increase the rate of anastomotic leakage. In this sense, studies that validate a standard technique of intracorporeal anastomosis in left colon surgery and that demonstrate its benefit with respect to extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied universally. Once the ICA technique is established, it will allow us to determine its non-inferiority compared to the standard technique performed up to now with extracorporeal anastomosis.

METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will be included into a prospective cohort and treated by laparoscopy with totally intracorporeal resection and anastomosis. They will be compared with a retrospective cohort of consecutive patients of identical characteristics treated by laparoscopy with extracorporeal resection and anastomosis, in the immediate chronological period.


Condition or disease Intervention/treatment
Colon Cancer Procedure: Extracorporeal left hemicolectomy anastomosis Procedure: Intracorporeal left hemicolectomy anastomosis

Detailed Description:

HYPOTHESIS Resection of the left colon / sigmoid with intracorporeal colorectal TT anastomosis is safe and not inferior to that performed extracorporeally. With the benefits of reduced intraoperative dissection, traction on the mesenteries, reduced vascular compromise of the anastomosis, a smaller incision size and being able to choose its location.

Main Aim:

The objective of this study is to demonstrate that colorectal mechanical end-to-end intracorporeal anastomosis is not inferior to extracorporeal approach in terms of anastomotic dehiscence.

Secondary Aims:

  • To demonstrate the reproducibility of the colorectal mechanical end-to-end intracorporeal anastomosis technique in terms of reconversion, anastomotic dehiscence, organo-cavitary infection, and other postoperative complications.
  • To determine the benefits that the IC anastomosis technique can bring to patients with obesity.
  • To determine the benefits that the IC anastomosis technique can provide in terms of postoperative complications, hospital stay, and size of the accessory incision.
  • To determine the benefit of the application of indocyanine green to determine the point of resection and anastomosis.

STUDY DESIGN

Comparative, single-center, controlled non-inferiority cohort study of resection and mechanical end-to-end intracorporeal anastomosis in left colon, sigmoid, and upper rectum surgery (prospective cohort) versus the standard technique of extracorporeal laparoscopic surgery (retrospective cohort).

SUBJECTS OF THE STUDY

In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique.

In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RESECTION AND INTRACORPOREAL ANASTOMOSIS IN LAPAROSCOPIC LEFT COLECTOMY AS AN ADAPTATION TO THE PANDEMIC CAUSED BY SARS-CoV-2 (COVID19). A COMPARATIVE COHORT STUDY
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022

Intervention Details:
  • Procedure: Extracorporeal left hemicolectomy anastomosis

    Standard surgical technique protocolized in the unit for laparoscopic surgery of the left colon, sigma and high rectum for the last 10 years.

    After sectioning the distal colon using a mechanical stapler (60mm blue load), a pfannestiel-type suprapubic accessory incision is made, with externalization of the tumor under wound protection with a ringed retraction device. Both the resection of the left mesocolon or mesosigma, and the placement of the head of the circular stapler are performed extracorporeally by proximal section of the colon with a pursetring® self-suturing device, removal of the piece, placement of the head, and reconnection of the pneumoperitoneum for colorectal anastomosis with Circular Stapler Curved B. Braun®

  • Procedure: Intracorporeal left hemicolectomy anastomosis

    o Intracorporeal resection of the left mesocolon

    The mesocolon resection will be performed totally intracorporeally to its proximal end. The distal colon section will be performed using a mechanical stapler (blue charge 60mm)

    o Preparation of Intracorporeal Anastomosis

    The anastomosis will be performed in a mechanical end-to-end manner using a Circular Stapler Curved B. Braun®.

    The Insertion of the stapler head into the proximal colon will be placed intracorporeally with an incision distal to the staple section. Once the head has been exteriorized at the terminal end of the proximal colon, a circular purse-type suture with prolene 2.0 will be made.

    Once the mechanical colorectal anastomosis is performed, 4-6 stitches of anastomotic reinforcement with silk 2.0 will be placed.

    The extraction of the piece will be carried out with endobag protection and with an accessory incision (pfannestiel or other location depending on the patient)



Primary Outcome Measures :
  1. Percentage of anastomotic leak (AL) [ Time Frame: 30 days ]
    Percentage of anastomic leak (defined in accordance with Peel et al.).


Secondary Outcome Measures :
  1. Rate of global morbidity [ Time Frame: 30 days ]
    Dindo-Clavien Classification

  2. Rate of Surgical site infection [ Time Frame: 30 days ]
    SSI in accordance with the Center for Disease Control (CDC) National

  3. Rate of Re-interventions [ Time Frame: 30 days ]
    Percentage of re-interventions due to surgical complications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique.

In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.

Criteria

Inclusion Criteria:

  • Left Colonic Adenocarcinoma. Location of the tumor in the left colon, sigma or high rectum (with the anastomosis performed above the peritoneal reflection). Non-metastatic stage. Scheduled oncological surgery with curative intention operated on with laparoscopic surgery with resection technique and intracorporeal anastomosis. Over 18 years

Exclusion Criteria:

  • Other tumor locations. Non-adenocarcinoma tumors. Synchronous tumors. T4 tumor stage and stage IV of TNM classification. ASA IV (American Society of Anesthesiologists). Non-optimal nutritional study (preoperative albumin ≤3.4 g / dl). Do not sign informed consent. Pregnant patients. Diagnosis of another type of neoplasm with active disease. Liver cirrhosis, Chronic kidney failure on dialysis treatment, patients with stent bridge to elective surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456933


Contacts
Layout table for location contacts
Contact: Xavier Serra-Aracil, MD,PhD 34-93-723-1010 ext 21490 jserraa@tauli.cat

Locations
Layout table for location information
Spain
Hospital Universitario Parc Tauli de Sabadel Recruiting
Sabadell, Barceelona, Spain, 08208
Contact: Xavier Serra-Aracil, MD,PhD    937 231 010‬ ext 21490    jserraa@tauli.cat   
Sponsors and Collaborators
Corporacion Parc Tauli
Irene Gómez Torres
Laura Mora López
Anna Pallisera-Lloveras
Sheila Serra-Pla
Albert García Nalda
Anna Serracant-Barrera
Mercedes Muñoz
Oriol Pino-Pérez
Investigators
Layout table for investigator information
Principal Investigator: Xavier Serra-Aracil, MD,PhD Corporacio Parc Tauli. Parc Tauli University Hospital
Publications:
Layout table for additonal information
Responsible Party: Xavier Serra-Aracil, Head of Colorectal Unit, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT04456933    
Other Study ID Numbers: HEMI-E-INTRACORPOREA-2020
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xavier Serra-Aracil, Corporacion Parc Tauli:
Left Colon Cancer,
Left hemicolectomy
Laparoscopic left hemicolectomy
Intracorporeal resection and anastomosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases